MAUDE Adverse Event Report: MEDTRONIC MEXICO PACIFIC PLUS; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number PCE050120130

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intimal Dissection (1333)

Event Date 08/18/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician used a pacific plus balloon for vessel pre dilation during a procedure to treat the mid to distal superficial femoral artery (sfa).The vessel was not severely calcified.There was no damage to device package.There was no issue noted when removing device from hoop/tray.The device was prepped per ifu with no issues identified.It is reported that a dissection was found after pre-dilation, so the physician used everflex entrust 6 150mm for stenting.The implant of the stent was not planned as part of the procedure.It is also reported that deployment issue of partial deployment occurred.There was no damage to deployment mechanisms or device handle prior to deployment issue.The thumbscrew/ lock-pin was checked for securement prior to procedure.The lock-pin was removed before stent deployment.The device did not pass through a previously deployed stent.There was no resistance felt while advancing the device.The stent was deployed smoothly at the beginning.When the stent was deployed around 80-90mm, the feedback of thumbscrew became abnormal, at the same time the outer sheath could not be pulled back and the stent could not be released.The physician slightly pulled back the whole delivery system and the rest of the stent was elongated.The target lesion was fully covered by the deployed elongated stent.The length of the deployed stent is 6.0mm in diameter and 150mm in length.There was no vessel damage caused by the stent.There was no further patient injury reported.

Manufacturer Narrative

Cine image review the first image is of a 5mm x 120mm pta balloon catheter being inflated within the targeted vessel anatomy; mid to distal superficial femoral artery.Per the initial reported event description, the pta balloon is a pacific plus pta balloon catheter that is 0.018¿ guidewire compatible.The second image indicates that the treated vessel exhibits dissection.The third image is of the distal end of the deployed stent within the targeted vessel anatomy.The distal portion of the stent exhibits normal deployment of the stent cell struts.The proximal portion stent in the image exhibits elongated stent cell structure.The fourth image is of the proximal end of the stent being deployed and elongated stent cell structure.The most proximal end of the stent is still compressed within the outer sheath of the entrust stent delivery system, (sds).The fifth image is of the proximal end of the stent and the most proximal end of the stent exhibits normal stent cell structure and the distal end of the stent exhibits elongated stent cell structure.The sixth image is a larger view of the fifth image.The seventh image is of the procedure report that show the ¿peel-off¿ label from the pacific plus pta catheter used in the procedure.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PACIFIC PLUS
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 10546169
• MDR Text Key: 207309202
• Report Number: 9612164-2020-03493
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K123358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2020
• Device Catalogue Number: PCE050120130
• Device Lot Number: 214421767
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 67