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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION XENFORM; MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO
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BOSTON SCIENTIFIC CORPORATION XENFORM; MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO Back to Search Results
Model Number M0068302470
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Urinary Retention (2119); Prolapse (2475); No Code Available (3191)
Event Date 01/18/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).The complainant indicated that the device is implanted and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a xenform soft tissue repair matrix was implanted during a pelvic floor reconstruction with xenform including apical suspension and cystocele repair procedure performed on (b)(6) 2015.According to the complainant, on (b)(6) 2017, the patient experienced pain.She was treated with physical therapy and the event has not yet resolved.The event is assessed as moderate in severity, pelvic floor related, possibly related to the procedure, and possibly related to the device.
 
Manufacturer Narrative
Patient id: (b)(6).(b)(4).Study name: (b)(6).The complainant indicated that the device is implanted and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a xenform soft tissue repair matrix was implanted during a pelvic floor reconstruction with xenform including apical vault suspension and cystocele repair procedure performed on (b)(6) 2015.According to the complainant, on (b)(6) 2016, the patient experienced rectal pain similar to pins and needles and was referred for physical therapy and for colon and rectal surgery.The event is assessed as resolving.The investigator assessed this event as moderate in severity, pelvic floor related, possibly related to the index procedure, and possibly related to the study device.On (b)(6) 2017, the patient experienced worsening pelvic pain (spontaneous, suprapubic, possibly related to muscle spasm).She was treated with physical therapy and the event is recovering.The event is assessed as moderate in severity, pelvic floor related, possibly related to the procedure, and possibly related to the device.On (b)(6) 2018, the patient experienced difficulty emptying bladder in relation to the anterior vaginal compartment.She was offered a pessary but declined.Her treatment included physical therapy and the event has not yet resolved.The investigator assessed the event as moderate in severity, pelvic floor related, possibly related to the index procedure, and possibly related to the device.
 
Manufacturer Narrative
Patient id: (b)(6).(b)(4).Study name: (b)(6).The complainant indicated that the device is implanted and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.(b)(4).
 
Event Description
It was reported to boston scientific corporation that a xenform soft tissue repair matrix was implanted during a pelvic floor reconstruction with xenform including apical vault suspension and cystocele repair procedure performed on (b)(6) 2015.According to the complainant, on (b)(6) 2016, the patient experienced pain similar to pins and needles and was referred to have colon and rectal surgery.The event is assessed as resolving.The investigator assessed this event as moderate in severity, pelvic floor related, possibly related to the index procedure, and possibly related to the study device.On (b)(6) 2017, the patient experienced worsening pelvic pain (spontaneous, suprapubic, possibly related to muscle spasm).She was treated with physical therapy and the event is recovering.The event is assessed as moderate in severity, pelvic floor related, possibly related to the procedure, and possibly related to the device.On (b)(6) 2018, the patient experienced difficulty emptying bladder in relation to the anterior vaginal compartment.She was offered a pessary but declined.Her treatment included physical therapy and the event has not yet resolved.The investigator assessed the event as moderate in severity, pelvic floor related, possibly related to the index procedure, and possibly related to the device.
 
Manufacturer Narrative
Patient id: (b)(6).Problem code 1994 captures the reportable event of pain.Study name: (b)(4)- xenform anterior/apical postmarket surveillance study.The complainant indicated that the device is implanted and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a xenform soft tissue repair matrix was implanted during a pelvic floor reconstruction with xenform including apical suspension and cystocele repair procedure performed on (b)(6) 2015.According to the complainant, on (b)(6) 2017, the patient experienced pain.She was treated with physical therapy and the event is recovering.The event is assessed as moderate in severity, pelvic floor related, possibly related to the procedure, and possibly related to the device.
 
Manufacturer Narrative
Patient id: (b)(6).Patient codes 1994 and 2119 capture the reportable events of pain and urinary retention.Study name: u9920 - xenform anterior/apical postmarket surveillance study.The complainant indicated that the device is implanted and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a xenform soft tissue repair matrix was implanted during a pelvic floor reconstruction with xenform including apical suspension and cystocele repair procedure performed on (b)(6) 2015.According to the complainant, on (b)(6) 2017, the patient experienced pain.She was treated with physical therapy and the event is recovering.The event is assessed as moderate in severity, pelvic floor related, possibly related to the procedure, and possibly related to the device.On (b)(6) 2018, the patient experienced difficulty emptying bladder in relation to the anterior vaginal compartment.She was offered a pessary but declined.Her treatment included physical therapy and the event has not yet resolved.The investigator assessed the event as moderate in severity, pelvic floor related, possibly related to the index procedure, and possibly related to the device.
 
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Brand Name
XENFORM
Type of Device
MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key6756015
MDR Text Key81465142
Report Number3005099803-2017-02243
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K060984
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/31/2018
Device Model NumberM0068302470
Device Catalogue Number72920
Device Lot Number0001509062
Was Device Available for Evaluation? No
Date Manufacturer Received01/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age71 YR
Patient Weight116
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