MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

Catalog Number	1235300-18
Health Effect - Clinical Code	Perforation (2001)
Date of Event	02/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.The reported patient effect of perforation, 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 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; however, the difficult to position (cross-ability) appears to be related to the circumstances of the procedure and there is no indication of a product quality issue with respect to design, manufacture or labeling of the device.The graftmaster stent and xience alpine stent are filed under separate manufacturer report numbers.
Event or Problem Description
It was reported that the patient underwent a procedure to treat a target lesion in the diagonal artery.Pre-dilatation was performed at the target lesion and the 3.0 x 18 mm absorb bioresorbable vascular scaffold (bvs) was implanted without difficulty.Post dilatation was performed and a perforation was noted distal to the scaffolded area.A 2.8 x 16 mm graftmaster stent was advanced to the perforation site, using a non-abbott guide catheter extension for support.Due to the patient anatomy, the use of the guide catheter extension and advancement distally through the implanted absorb, resistance was met and positioning was difficult; therefore, the 2.8 x 16 mm graftmaster did not fully cover the perforation but sealed the area where it was implanted.A second 2.8 x 19 mm graftmaster stent delivery system was advanced and was able to cover the remaining perforation.During use of the non-abbott guide catheter extension, as the guide catheter extension was engaged in the left anterior descending artery, a dissection occurred (caused by the guide catheter extension).A 3.0 x 15 mm xience alpine was advanced to the dissection and deployed.Post-dilatation was performed using a 4.0 x 15 mm nc trek.After the nc trek was removed, the dissection flap was noted to cover the diagonal artery, occluding flow into the diagonal artery.No additional intervention was performed to treat the occlusion.During the procedure, the patient remained pain-free.Post-procedure, a small amount of blood was noted in the pericardium; however, this was not treated.The patient was discharged from the cath lab in stable condition.No additional information was provided.

• Brand Name: ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Common Device Name: BIORESORBABLE DRUG ELUTING SCAFFOLD
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6386402
• Report Number: 2024168-2017-01903
• Device Sequence Number: 16294422
• Product Code: PNY
• UDI-Device Identifier: 08717648213045
• UDI-Public: (01)08717648213045(17)170901(10)6090261
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P150023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2017
• Device Catalogue Number: 1235300-18
• Device Lot Number: 6090261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2017
• Initial Report FDA Received Date: 03/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DIL CATH: 3.0X15MM NC TREK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR