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

Catalog Number 1012463-28

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

Patient Problem Intimal Dissection (1333)

Event Date 10/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: scaffold: absorb 3.5x18mm, dilatation catheter: 3.0x12 mm trek nc.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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of dissection, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use (ifu), is a known adverse event associated with the use of a coronary scaffold in native coronary arteries.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined and the treatment appears to be related to the circumstances of the procedure.

Event Description

It was reported that the procedure was to treat a long discrete lesion located in the proximal left anterior descending (lad) artery with moderate tortuosity, mild calcification and 95% stenosis.A 3.0x28mm absorb was implanted in the distal part of the lesion and a 3.5x18mm absorb was implanted in the proximal part of the lesion with 10 atmospheres (atm) pressure and held for about 30 seconds.Post-dilatation was performed using a 3.5x12 mm trek nc proximally and 3.0x12 mm trek nc distally with 18 atm pressure.After post-dilation, an edge dissection was noted at the distal edge of the 3.0x28mm absorb.A 3.0x12mm absorb was deployed to cover the dissection.There was a good final patient outcome.There was no adverse patient sequelae or clinically significant delay in procedure.No additional information was provided.

• 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: 6094920
• MDR Text Key: 59727255
• Report Number: 2024168-2016-07880
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648157042
• UDI-Public: (01)08717648157042(17)170201(10)602036A
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2017
• Device Catalogue Number: 1012463-28
• Device Lot Number: 602036A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• 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
• Patient Age: 53 YR