MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

Catalog Number 1012464-23

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The investigation was unable to determine a conclusive cause for the reported scaffold recoil.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the index procedure on (b)(6) 2016 was to treat a lesion located in an unspecified vessel in the coronary.A 3.5x23mm absorb scaffold was successfully implanted.The absorb scaffold was post-dilatated with an unknown nc balloon.Scaffold recoil was noted (about 50%) which was treated by overstenting the already placed scaffold using another unknown drug eluting stent.There were no adverse patient effects or clinically significant delay in procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).A cine was received and reviewed by an abbott vascular clinical specialist who concluded the following: an absorb was implanted in a tight angled lesion in the circumflex after minimal pre-dilatation.The absorb was seen to be quickly inflated but never fully expanded.Within the scaffolded segment there was an under-expanded area which corresponds to the tight angulated area seen initially.Post-dilatation was performed but the balloon dilatation catheter appeared to be small compared to the proximal vessel and the under-expanded area persisted.The scaffolded area was treated with metallic stent placement and the vessel appeared well expanded.

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE DRUG ELUTING SCAFFOLD
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5865980
• MDR Text Key: 51776066
• Report Number: 2024168-2016-05293
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648157110
• UDI-Public: (01)08717648157110
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012464-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2016
• Initial Date FDA Received: 08/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention